Cancer Center

EmailEmail    |   Bookmark Page Bookmark  |   RSS Feeds RSS  |   Print Page Print  

Clinical Trials Office SOPs

Click on the name of the SOP to view or download the document. 


 CCCTO SOP Glossary of Common Terms & Definitions **Working Document**

1.    Administrative SOPs

1.1.   SOP on SOPs  **Posted 4/29/14**

1.2.   Change Management SOP  **Posted 4/29/14**

1.3.   Organizational SOP

1.4.   Education/Training

1.5.   Notifications

2.     Study Selection

2.1.   Identify Protocols

 2.1.1.     CDA

 2.1.2.     Feasibility

2.2.  Select Protocols

 2.2.1.     Research Manager Review

 2.2.2.     Faculty Disease Committee Review

 2.2.3.     Scientific Review Committee

3.     Study Feasibility

3.1.  Develop/Process Contracts

3.2.  Budget/Logistics Development 

 3.2.1.     Study calendar creation

 3.2.2.     Standard of care/research determinations

 3.2.3.     Pricing

3.3.  Ancillary Committees

3.4.  Gather/Develop Site Documentation

4.     Study Setup

4.1.   Logistic Finalization

4.1.1.       Required protocol training **Posted 4/29/14**

4.1.2.      Site initiation visits

4.1.3.      Clinicaltrials.gov submission/updating

4.1.4.      IND Application

4.2.  IRB Submissions

4.2.1.     New submissions

4.2.2.     Emergency Use Protocols

4.2.3.     Compassionate Use Protocols

4.3.  Accounting

4.4   Protocol Implementation Meetings v2.0 **Posted 4/29/14**

5.     Study Conduct

5.1.   Notification of Study Opening to Enrollment

5.2.   Pre-screening

5.3.   Patient Screening & Enrollment **Posted 4/29/14**

5.4.   Schedule Services

5.5.   Research Billing Management

5.7.  Study Subject Unblinding **Posted 12/8/14**

6.     Ongoing Processes

6.1.  Study Monitors & Monitoring Visits v2.0 **Posted 4/29/14**

6.2.  Regulatory

6.2.1.   Amendments

6.2.2.   CPRs

6.2.3.   Reportable Events

6.2.4.   External Safety Reports – Industry Sponsored **Posted 4/29/14**

6.2.5.   External Safety Reports – Cooperative Groups **Posted 4/29/14**

6.2.6.   General

    6.2.6.1.   Uploading study documents in Oncore

    6.2.6.2.   Regulatory document preparation & retention

         6.2.6.2.1.  Completing the 1572 & Financial Disclosures **Posted 4/29/14**

 6.2.6.2.2.  Completing the Delegation of Authority Log **Posted 4/29/14**

                                      6.2.6.2.3.  Investigator Brochure Version Control **Posted 12/8/14**

             6.3. Clinical Research Coordinators

6.3.1.     Randomizing a patient

6.3.2.     Recording patient visits

6.3.3.     Locating Current IRB Approved Protocol Documents

6.3.4. Consenting Study Subjects **Posted 11/7/14**

6.3.5.     Data Entry/CRF Completion

6.4.  Principle Investigators

6.4.1.      Financial disclosures, etc. timelines

6.5. General

6.5.1.     Audit Preparation

6.5.2.     Internal Audits

6.5.3.     External Audits **Posted 4/29/14**

6.5.4.     Planned Study Transition Between CTO Employees **Posted 4/29/14**

6.5.5.     CTO Employee Resignation **Posted 4/29/14**

6.5.6.    Use of Care Everywhere in Epic for Clinical Trials **Posted 4/29/14**

7.     Study Closure

7.1.   Closing a study to enrollment

             7.2.   Notification of Study Closure to Accrual

CTO SOP Distribution List


If you'd like to be included on the mailing list for Cancer Center Clinical Trials Office SOP updates, please enter your email address and name in the form below.   

 

email Address

First and Last Name

Contact the CTO

Search Active Clinical Trials Here

 

Adult Cancer Clinical Trials 

Medical College of Wisconsin

Cancer Center Clinical Trials Office (CTO)

9200 W. Wisconsin Ave.

Milwaukee, WI 53226

Phone 414-805-8900

Fax 414-805-0596

cccto@mcw.edu

 

Pediatric Cancer Clinical Trials

Jennifer Brown

Clinical Research Manager

Pediatric Hematology, Oncology & Transplant

Medial College of Wisconsin

MACC Fund Center for Cancer & Blood Disorders

Phone 414-266-8914

Fax 414-955-0116

jlbrown@mcw.edu

 

OnCore Clinical Trials Management System

Sandra Johnson

OnCore System Administrator 

Medical College of Wisconsin 

Cancer Center Clinical Trials Office (CTO)

Phone: 414-805-4376

sjohnson@mcw.edu 

webmaster@mcw.edu
© 2014 Medical College of Wisconsin
Page Updated 12/08/2014